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Mozart Relapse Study

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Ziprasidone
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects who have completed MOZART study and who are responders to Ziprasidone: Responders: patients with a 20% or more reduction in the PANSS total score at the endpoint of the Mozart Study (recorded at V18 in the Mozart) as compared with the baseline value Patients not hospitalised in an acute psychiatric service Written, informed consent to participation. Female patients of at risk of pregnancy must avoid to remain pregnant; if already used, an adequate method of contraception can be continued Exclusion Criteria: Psychiatric: Subjects with a score of greater than or equal to 5 and an increase of at least 2 points (with respect to baseline value of MOZART study) at one of the following PANSS items: P7 (hostility), G8 (uncooperativeness) or G14 (poor control impulse) Subjects with a score equal to 3 and an increase of at least 1 point (with respect to baseline value of MOZART study) at item 8 (suicide) of CDSS General: Patients who, during MOZART study, have developed one of the following diseases will be excluded: (or patients who do not satisfy anymore one of the following general exclusion criteria of MOZART study) Subjects with a history of clinically significant and/or currently relevant haematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer. Controlled Type II diabetes (glucose < 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study Patients with a non stabilized somatic disease - Acute or chronic heart disease Clinically significant ECG abnormalities Subjects with QTc greater than or equal to 500 msec (subjects with QTc greater than or equal to 450 msec and < 500 msec should be discussed with the cardiologist) - Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments) Subjects with serum K+ outside the normal range History of seizure (should be discussed with the Sponsor) Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator Pregnant or lactating women Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends Subjects unable or unlikely to follow the study protocol Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds Diagnosis of substance dependence using DSM-IV criteria (305.xx) Positive urine drug screen at screening for amphetamines, cocaine or opioids

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

long-term efficacy of oral Ziprasidone in the maintenance treatment

Secondary Outcome Measures

To assess the efficacy of ziprasidone in the relapse prevention of schizophrenia To collect long-term data on safety and tolerability of oral Ziprasidone

Full Information

First Posted
August 31, 2005
Last Updated
February 18, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00143351
Brief Title
Mozart Relapse Study
Official Title
Open Extension Study Evaluating the Long-term Efficacy, Safety, and Tolerability of Oral Ziprasidone in the Treatment of Resistant/Intolerant Schizophrenic Patients Who Have Acutely Responded to Ziprasidone in the Mozart Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
To assess the long-term efficacy of oral Ziprasidone in the maintenance treatment of resistant schizophrenic subjects who have benefited from participation in the phase III ziprasidone study A1281039 (MOZART study), to assess the efficacy of ziprasidone in the relapse prevention of schizophrenia, to collect long-term data on safety and tolerability of oral Ziprasidone

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
75 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Ziprasidone
Primary Outcome Measure Information:
Title
long-term efficacy of oral Ziprasidone in the maintenance treatment
Secondary Outcome Measure Information:
Title
To assess the efficacy of ziprasidone in the relapse prevention of schizophrenia To collect long-term data on safety and tolerability of oral Ziprasidone

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who have completed MOZART study and who are responders to Ziprasidone: Responders: patients with a 20% or more reduction in the PANSS total score at the endpoint of the Mozart Study (recorded at V18 in the Mozart) as compared with the baseline value Patients not hospitalised in an acute psychiatric service Written, informed consent to participation. Female patients of at risk of pregnancy must avoid to remain pregnant; if already used, an adequate method of contraception can be continued Exclusion Criteria: Psychiatric: Subjects with a score of greater than or equal to 5 and an increase of at least 2 points (with respect to baseline value of MOZART study) at one of the following PANSS items: P7 (hostility), G8 (uncooperativeness) or G14 (poor control impulse) Subjects with a score equal to 3 and an increase of at least 1 point (with respect to baseline value of MOZART study) at item 8 (suicide) of CDSS General: Patients who, during MOZART study, have developed one of the following diseases will be excluded: (or patients who do not satisfy anymore one of the following general exclusion criteria of MOZART study) Subjects with a history of clinically significant and/or currently relevant haematological, renal (including single kidney), hepatic, gastrointestinal, endocrine (except for current adequately treated hypo- or hyperthyroidism), pulmonary (excluding chronic bronchitis, mild emphysema or chronic obstructive pulmonary disease), dermatological, oncological, or neurological disease, excluding tardive dyskinesia but including all forms of epilepsy (febrile convulsions in childhood acceptable). The only subjects with known prior malignant disease who are eligible are those with cured prior skin cancer. Controlled Type II diabetes (glucose < 180 mg/100 ml at screening and baseline with dietary or oral hypoglycemic treatment) will not be considered a significant medical illness and would not exclude a subject from the study Patients with a non stabilized somatic disease - Acute or chronic heart disease Clinically significant ECG abnormalities Subjects with QTc greater than or equal to 500 msec (subjects with QTc greater than or equal to 450 msec and < 500 msec should be discussed with the cardiologist) - Concomitant treatment with medications that prolong QTc interval (please review prescribing information of other treatments) Subjects with serum K+ outside the normal range History of seizure (should be discussed with the Sponsor) Subject with any confirmed laboratory values that deviate from the upper or lower limits of normal prior to study entry, except for clinically insignificant deviations as determined by investigator Pregnant or lactating women Subjects who intend to donate blood or blood products during the 4 weeks prior to the study, during the study or in the 30 days after the study ends Subjects unable or unlikely to follow the study protocol Subjects with a history of neuroleptic malignant syndrome developing from the administration of antipsychotic compounds Diagnosis of substance dependence using DSM-IV criteria (305.xx) Positive urine drug screen at screening for amphetamines, cocaine or opioids
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Vicenza
State/Province
Bassano DEL Grappa
ZIP/Postal Code
36061
Country
Italy
Facility Name
Pfizer Investigational Site
City
Citta' Di Castello
State/Province
Perugia
ZIP/Postal Code
06012
Country
Italy
Facility Name
Pfizer Investigational Site
City
Bari
ZIP/Postal Code
70100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Brescia
ZIP/Postal Code
25100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
Pfizer Investigational Site
City
Guardiagrele (CH)
ZIP/Postal Code
66016
Country
Italy
Facility Name
Pfizer Investigational Site
City
Messina
ZIP/Postal Code
98100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00135
Country
Italy
Facility Name
Pfizer Investigational Site
City
Roma
ZIP/Postal Code
00137
Country
Italy
Facility Name
Pfizer Investigational Site
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Facility Name
Pfizer Investigational Site
City
Terni
Country
Italy
Facility Name
Pfizer Investigational Site
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Trieste
ZIP/Postal Code
34126
Country
Italy
Facility Name
Pfizer Investigational Site
City
Verona
ZIP/Postal Code
37100
Country
Italy

12. IPD Sharing Statement

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Mozart Relapse Study

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